Director, Regulatory Affairs

Posted 2 days ago

immunocoreOxford (PA)

Regulatory Affairs Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

SALARY

$157,500 per year

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About the role

Job Details: Director, Regulatory Affairs-Global Regulatory LeadFull details of the job.|||| --- | --- |||||||| --- | --- ||| Director, Regulatory Affairs-Global Regulatory Lead ||| VN723 ||| Full Time ||| Gaithersburg, MD, Radnor, PA, Oxford, UK ||| Regulatory Affairs ||| The Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore’s development programs to include: Regulatory scientific and tactical strategy development, IND development/submission /maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. The role will also involve interacting with our global sites, both in-house and outsourced. Establishing a successful relationship with the FDA, along with being responsible for overseeing submissions to the EMA, MHRA, and other local Health Authorities providing an excellent opportunity to develop worldwide regulatory experience. The ideal candidate will have experience gained in biologics and the preparation of late-stage regulatory fillings, with regulatory tactical leadership skills and implementation. This role will also require someone who can work within a highly innovative, agile, and entrepreneurial environment and is able to lead the regulatory strategy through effective collaboration and be able to deliver and work well under pressure as this will be a high-profile role.

KEY RESPONSIBILITIES:

To provide regulatory leadership and support to cross functional development project teams to jointly achieve strategic objectives.
To be responsible for the US and ex-US regulatory activities associated with the project teams.
Develop regulatory scientific, and tactical strategic plans, and target labelling to support product development of products.
Provide leadership for the development and writing of regulatory submission documents, including Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.
You will manage, prepare, co-ordinate and be responsible for the submission of the documentation supporting regulatory submissions to the US and wider international regulatory authorities, in support of CTA/INDs, BLAs/MMAs, CTA safety reports and updates, along with all other regulatory submissions.
To be the center of excellence (point of contact) of all regulatory requirements and guidelines globally, in particular within the US, and monitoring the regulatory environment for oncology, antifectives, autoimmune diesases, and biologics.
Contribute to the establishment and development of procedures and working practices commensurate with the requirements of a company in late-stage development and commercialization.
Overseeing regulatory review of clinical trial labelling and CMC submissions for regulatory compliance, in conjunction with the Director of Regulatory CMC.
Will need to demonstrate a high level of professionalism, efficiency, and leaderships within the team whilst demonstrating critical thinking, effective problem solving and a strong knowledge of regulatory strategies and compliant with all regulations and guidance.
To be responsible for reviewing and ensuring the quality of detailed scientific and technical information are presented clearly and supporting conclusions are adequately evidenced by the data. SUPERVISORY RESPONSIBILITYThis position does not initially have direct reports but may in the future. COMPETENCIES1. Communication Proficiency.2. Time Management.3. Collaboration Skills.4. Personal Effectiveness/Credibility.5. Flexibility.6. Technical Capacity.7. Stress Management/Composure. IMMUNOCORE VALUES
We lead with science to benefit patients
We are entrepreneurial
We value diversity to drive innovation
We respect each other and act with integrity
We do the right thingPERSON SPECIFICATIONEXPERIENCE & KNOWELEDGEEssential
Solid track record in drug development and leadership within a dynamic project team(s)
Solid scientific background with evidence of emerging ability to develop regulatory scientific strategies.
Strong understanding of global regulatory requirements to be able to form functional regulatory strategies.
Excellent knowledge of US regulatory requirements and extensive experience with submissions gained within drug development. Global experience desirable. Experience in working cross functionally and globally within Regulatory Affairs.
Experience in supporting global clinical studies
Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs. Submission of at least 1 NME BLA/NDA is highly desirable.
Experience in preparing for, and conducting Health Authority Meetings (FDA required). Ability to develop and maintain an ongoing liaison relationship with FDA and other global Health Authorities.
Demonstrate ability to be agile to accommodate changing priorities
Must have proven leadership, excellent communication and interpersonal skills. Preferred Experience & knowledge
Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs. Submission of at least 1 NME BLA/NDA is highly desirable.
Experience in preparing, and conducting Health Authority Meetings (FDA required). Ability to develop and maintain an ongoing liaison relationship with FDA and other global Health Authorities.

EDUCATION & QUALIFICATIONS: Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 5-10 years’ experience or BS with 8-12 years’ experience. POSITION TYPE & EXPECTED HOURS OF WORK / TRAVELThis is a Full Time, Exempt position: Occasional overtime may be required based on work priorities, outside of general office hours. Limited overnight travel is expected for this position. There may be occasional local day travel. US Salary Range$157,500- $262,500 ||| Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law. |

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